Thermo Fisher Scientific

Job Description

Summarized Purpose: Manages the day to day activities, performance and supervision of the research site. Ensures execution of site protocols and providing daily direction to the site’s staff. Acts as the liaison between the investigator and the research team and ensures the execution and coordination of clinical research activities according to the organization’s SOPs, ICH/GCP and FDA guidelines. Supports the global aligned business objectives, growth, delivery of targets, quality management as well as the appropriate planning and coordinating of resources and facilities.

• This position is located full onsite at our Birmingham, Alabama facility. Relocation assistance is possible for this opportunity*

Essential Functions and Other Job Information:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Manages site activities to ensure delivery of site targets as received from senior management.
• Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.
• Responsible for cost efficiencies within the site and all vendor contracts for services at the site.
• Continuously oversees the schedules of site staff to ensure highest utilization of all resources.
• Evaluates and implements new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the site.
• May provide input in the feasibility process, considering both recruitment and operational concerns.
• Communicates targets to the site teams and continuously measures progress.
• Plans and prepares proactively for future studies according to new and defined strategies, embracing and implementing new TA area initiatives at the sites.
• Collaborates with site and management regarding capacity planning and back-up plans, arranging and attending meetings.
• Ensures patient recruitment activities are adequate for study requirements.
• Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS).

Policy & Strategy: Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility. Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company (“PPD”), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.

Freedom to Act: Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives. A portion of the time may be spent performing individual tasks.

Liaison: Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues.

Qualifications:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• 1+ year of leadership responsibility In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Advanced computer skills with proficiency in Microsoft office and content management software and the ability to learn appropriate software/hardware (i.e. EDC, eCRF and possibly IT/SQL skills but not essential)
• Strong attention to detail
• Good problem-solving abilities
• Good organizational and time management skills
• Excellent oral and written communications skills
• In-depth perspective and knowledge to represent IGC on task forces or teams • Demonstrated ability to analyze data, determining root cause of deficiencies and providing recommendations for resolution
• Skilled in leading process improvement activities
• Ability to successfully mentoring and training junior staff
• Proficiency in the review and analysis of audit reports
• Effective coaching and counselling skills
• Ability to read, understand and interpret a protocol
• Knowledge of clinical trial process and data management, clinical operations, quality management, and systems applications to support operations
• Strong communication skills and business acumen

Management Role: Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department. Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company (“PPD”), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Moderate mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.
• Ability to apply basic principles to solve conceptual issues.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Percent Billable: 80% - 100%